What should consumers know before being treated with therapies derived from stem cells?

As is the case with any investigational treatment, consumers should speak with their doctor to learn about the potential risks and benefits from being treated with a stem cell-based product. Consumers should seek assurance from their treating physician that necessary FDA approval has been obtained, or that they will be part of a clinical study being conducted in accordance with FDA regulations before proceeding with treatment.

What should consumers know before seeking stem cell treatments outside the U.S.?

Consumers should also be aware that in most cases FDA has not reviewed data associated with the products offered in other countries, including stem cell-based products, and can not comment on their safety and effectiveness. It is also important to understand that treatments offered in other countries may not be subject to the same level of regulatory oversight as products marketed in the U.S. FDA encourages consumers to learn all they can about the regulations covering any stem cell-based product they are considering, and to ask questions of the regulatory authority in the country where the treatment will be received. Consumers should exercise caution before undergoing treatment with a stem cell-based product in a country that does not require adequate and well-controlled studies to demonstrate both safety and efficacy.

What are some of the safety concerns with stem cell treatments?

While stem cell therapies theoretically have potential promise, their use also raises a number of safety concerns including: the ability of the cells to migrate from the site of administration and differentiate (or change) into inappropriate cell types; excessive cell growth; and the development of tumors. These safety concerns must be addressed as part of the risk/benefit evaluation of these products.